Pediatric Rheumatology Collaborative Study Group (PRCSG)
The Pediatric Rheumatology Collaborative Study Group (PRCSG), founded in 1973, is a consortium of 93 academic pediatric rheumatology centers whose chief aim is to conduct high quality clinical trials of therapeutic agents in children with rheumatic diseases. The PRCSG has carried out and reported or is in the process of conducting a total of 36 trials in children with JRA with many additional publications relating to methodological issues and secondary analyses of the trial database. The PRCSG has performed almost all the trials of treatments for JRA in North America since 1977.
Daniel Lovell, MD, MPH, has been the Chairman of the PRCSG since 1991. Edward H. Giannini, MSc, DrPH, has been the Senior Scientist of the group since 1976.
The Coordinating Center for the PRCSG is located in the Clinical Trials Unit, which is part of the Division of Rheumatology at Cincinnati Children's Hospital Medical Center.
Drugs previously tested include:
- Various NSAIDs
- Hydroxychloroquine
- D-penicillamine
- Different dosage levels of MTX
- Intravenous immunoglobulin
- Etanercept
- Anakinra
Except for the earliest of these studies (tolmetin sodium in the treatment of JRA), Drs. Giannini and / or Dr. Lovell have served as the designers and coordinators for all of the studies. Numerous secondary analyses that used data generated in the initial studies have provided meaningful answers to important clinical questions. These investigators developed and validated the currently accepted measure of clinical response used in clinical trials involving children with JRA. This definition of clinical response was successfully utilized in the trial of the TNFa blocker, etanercept, in children with severe JRA.
These same investigators also designed and performed the validation study of the Childhood Myositis Assessment Scale and have been actively involved in the definition of core sets of outcome measures and definitions of improvement for children with Juvenile idiopathic inflammatory myopathies. Recent, the PRCSG, in collaboration with the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Pediatric Rheumatology InterNational Trials Organization (PRINTO) developed a preliminary definition of clinical remission for children with JRA.
Publications from the PRSCG:
Lovell, D.J., et al., Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med, 2000. 342(11): p. 763-9.
Giannini EH, R.N., Ravelli A, Lovell DJ, Martini A, Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum, 1996. 39: p. S56.
Giannini, E.H., D.J. Lovell, and B. Hepburn, FDA draft guidelines for the clinical evaluation of antiinflammatory and antirheumatic drugs in children. Executive summary. Arthritis Rheum, 1995. 38(5): p. 715-8.
Giannini, E.H., et al., Intravenous immunoglobulin in the treatment of polyarticular juvenile rheumatoid arthritis: a phase I/II study. Pediatric Rheumatology Collaborative Study Group. J Rheumatol, 1996. 23(5): p. 919-24.
Giannini EH, C.J., Brewer EJ, Shaikov A, Maximov A, Kuzmina N, Comparative efficacy and safety of advanced drug therapy in children with juvenile rheumatoid arthritis. Semin. Arthritis Rheum, 1993. 23: p. 34-46.
Lovell, D.J., et al., Development of validated disease activity and damage indices for the juvenile idiopathic inflammatory myopathies. II. The Childhood Myositis Assessment Scale (CMAS): a quantitative tool for the evaluation of muscle function. The Juvenile Dermatomyositis Disease Activity Collaborative Study Group. Arthritis Rheum, 1999. 42(10): p. 2213-9.
Giannini, E.H., et al., Ibuprofen suspension in the treatment of juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. J Pediatr, 1990. 117(4): p. 645-52.
Giannini, E.H., et al., Auranofin in the treatment of juvenile rheumatoid arthritis. Results of the USA-USSR double-blind, placebo-controlled trial. The USA Pediatric Rheumatology Collaborative Study Group. The USSR Cooperative Children's Study Group. Arthritis Rheum, 1990. 33(4): p. 466-76.
Giannini, E.H., et al., Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group. N Engl J Med, 1992. 326(16): p. 1043-9.
Giannini, E.H., Pediatric Rheumatology Collaborative Study Group: Results of the auranofin long-term follow up program (AU109X) in children with juvenile rheumatoid arthritis. J Rheumatol, 1992. suppl 33, 114 abstract.
Giannini, E.H. and J.T. Cassidy, Methotrexate in juvenile rheumatoid arthritis. Do the benefits outweigh the risks? Drug Saf, 1993. 9(5): p. 325-39.
Giannini EH, N.A., Fink CW, Low-dose methotrexate in children with JRA. Results of a post-trial long-term follow-up program. Arthritis Rheum, 1993. 36: p. 36 (suppl) S54 (abstract).
Levinson, J.E., et al., Comparison of tolmetin sodium and aspirin in the treatment of juvenile rheumatoid arthritis. J Pediatr, 1977. 91(5): p. 799-804.
Silverman, E.D., et al., Intravenous immunoglobulin in the treatment of systemic juvenile rheumatoid arthritis: a randomized placebo controlled trial. Pediatric Rheumatology Collaborative Study Group. J Rheumatol, 1994. 21(12): p. 2353-8.
Reiff A, P.O., Rudge S, Punaro M, Allen R, Ilowite N, Martin A, Lovell D, Kazazi F, Sun G, Newmark R., Preliminary Data from a Study of Kinernet&153; (anakinra) in Children with Juvenile Rheumatoid Arthritis. Arthritis Rheum, 2002. 46(9): p. S215.
Lovell, D.J., E.H. Giannini, and E.J. Brewer, Jr., Time course of response to nonsteroidal antiinflammatory drugs in juvenile rheumatoid arthritis. Arthritis Rheum, 1984. 27(12): p. 1433-7.
van Kerckhove, C., E.H. Giannini, and D.J. Lovell, Temporal patterns of response to D-penicillamine, hydroxychloroquine, and placebo in juvenile rheumatoid arthritis patients. Arthritis Rheum, 1988. 31(10): p. 1252-8.
Ruperto, N. and E.H. Giannini, Redundancy of conventional articular response variables used in juvenile chronic arthritis clinical trials. Ann Rheum Dis, 1996. 55(1): p. 73-5.
Giannini, E.H. and E.J. Brewer, Poor correlation between the erythrocyte sedimentation rate and clinical activity in juvenile rheumatoid arthritis. Clin Rheumatol, 1987. 6(2): p. 197-201.
Giannini, E.H., et al., Characteristics of responders and nonresponders to slow-acting antirheumatic drugs in juvenile rheumatoid arthritis. Arthritis Rheum, 1988. 31(1): p. 15-20.
Giannini EH, L.D., Felson DT, Goldsmith CH, Preliminary core set of outcome variables for use in JRA clinical trials. Arthritis Rheum, 1994. 39: p. S428.
Rider L, G.E., Lovell D, Isenberg D, Pilkington C, Cronin M, Feldman B, Finkel R, et.al and the International Myositis Outcome Assessment Collaborative Study Group, Defining Clinically Relevant Change in Core Set Activity Measures for Adult and Juvenile Idiopathic Inflammatory Myopathies (IIM). Arthritis Rheum, 2002. 46(9): p. S613.
Rider, L.G., et al., Defining Clinical Improvement in Adult and Juvenile Myositis. J Rheumatol, 2003. 30(3): p. 603-17.
Wallace CA, Ruperto N, Giannini EH, for the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Pediatric Rheumatology InterNational Trials Organization (PRINTO), and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Preliminary criteria for clinical remission for selected categories of juvenile idiopathic arthritis. Journal of Rheumatology, 2004; 31:2290-2294.
For more information about the William S. Rowe Division of Rheumatology at Cincinnati Children's, please contact 513-636-8071, fax 513-636-5990.
Pediatric Rheumatology Collaborative Study Group
Att: Dr. Daniel Lovell
3333 Burnet Avenue, MC 4010
Cincinnati, OH 45229
